Voxzogo (Vosoritide)

Description

Voxzogo (vosoritide) is a C-type natriuretic peptide (CNP) analog indicated for the treatment of achondroplasia in patients who are 5 years of age and older with open epiphyses, as confirmed by radiographic evaluation. Achondroplasia is the most common form of dwarfism caused by a gain-of-function mutation in the FGFR3 gene, which inhibits bone growth. Vosoritide acts as a positive regulator of endochondral bone growth by counteracting the effects of the overactive FGFR3 signaling pathway. This results in increased linear growth velocity and improved skeletal development in children with achondroplasia.

Directions

Voxzogo is administered by subcutaneous injection once daily. The recommended dosage is 15 micrograms per kilogram of body weight. Dose adjustments may be necessary based on growth response and tolerability. Injections should be given at approximately the same time each day, and the injection site should be rotated to minimize local reactions. Treatment should be continued as long as the epiphyses remain open. Patients and caregivers must be trained on proper reconstitution and injection technique. Regular monitoring of growth parameters and skeletal development is required during treatment.

Ingredients

Each vial of Voxzogo contains:

• Vosoritide (0.4 mg, 0.56 mg, or 1.2 mg per vial)

• Mannitol

• Trehalose dihydrate

• Tris hydrochloride

• Tris base

• Polysorbate 20

• Hydrochloric acid and/or sodium hydroxide (for pH adjustment)

The product must be reconstituted with the supplied sterile water for injection before use.

Contraindications

Voxzogo is contraindicated in patients with:

• Hypersensitivity to vosoritide or any of the excipients

• Closed epiphyses, as the therapy is not effective once bone growth plates are fused

Cautions

Blood pressure should be monitored during treatment, particularly shortly after injection, as Voxzogo can cause transient decreases in blood pressure. Caution is advised in patients with underlying cardiovascular disease or dehydration. The safety and effectiveness of Voxzogo in children under 5 years of age or in those with other causes of short stature have not been established. Growth velocity should be monitored regularly, and treatment discontinued if no benefit is observed over time.

Side Effects

Common side effects of Voxzogo include:

• Injection site reactions (erythema, swelling, pruritus)

• Vomiting

• Arthralgia

• Decreased blood pressure (transient)

• Headache

• Hypotension-related symptoms (e.g., dizziness, fatigue)

Less common but potentially serious side effects include hypersensitivity reactions and hypotension requiring medical attention. Patients should be monitored closely during dose escalation or changes in health status.

Product Code : 14903